MAUDE Adverse Event Report: CARDIVA MEDICAL, INC CARDIVA VASCADE 6/7F VCS

Model Number	700-580I
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/27/2016
Type of Reportable Event	Malfunction
Event or Problem Description
The device was inserted into the sheath, the disc was deployed, temporary hemostasis was achieved and the sheath was removed.The doctor inserted the key into the lock and retracted the black sleeve without issue.The collagen was deployed, the disc was de-deployed and the device was removed.Final hemostasis was achieved with the device.After device was removed from patient and pressure was being held the cardiva lrepresentative noticed a separation of the distal outer sleeve from the joiner.The distal outer sleeve was still on the device.

• Brand Name: CARDIVA VASCADE 6/7F VCS
• Common Device Name: VASCADE 6/7F
• Manufacturer (Section D): CARDIVA MEDICAL, INC; 2900 lakeside drive; suite 160; santa clara CA 95054 2817
• MDR Report Key: 5455729
• Report Number: 3004182619-2016-00002
• Device Sequence Number: 256160
• Product Code: MGB
• UDI-Device Identifier: M729700580I0
• UDI-Public: +M729700580I0/$$7C580I151110AH
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P120016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 11/30/2017
• Device Model Number: 700-580I
• Device Catalogue Number: N/A
• Device Lot Number: 580I151110A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2016
• Initial Report FDA Received Date: 02/23/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 82